K013751 is an FDA 510(k) clearance for the HANDHELD GAMMA FINDER (HGF). This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Silicon Instruments Gmhb (Berlin, DE). The FDA issued a Cleared decision on February 6, 2002, 85 days after receiving the submission on November 13, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K013751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2001 |
| Decision Date | February 06, 2002 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |